美国药品NDC(国家药品编码)与药品说明书数据库(U.S. FDA National Drug Code DataBase)
检索条件:" 注册申请号=ANDA207551"
NDC包装代码 产品NDC 产品类型 商品名 通用名 剂型 给药途径 上市日期 结束日期 市场类别 申请号 标签持有者 活性成分 规格 包装描述
70121-1388-8 70121-1388 HUMAN PRESCRIPTION DRUG Dexmedetomidine Hydrochloride Dexmedetomidine Hydrochloride INJECTION, SOLUTION INTRAVENOUS 20200520 N/A ANDA ANDA207551 Amneal Pharmaceuticals LLC DEXMEDETOMIDINE HYDROCHLORIDE 4 ug/mL 20 BOTTLE, GLASS in 1 CARTON (70121-1388-8) / 50 mL in 1 BOTTLE, GLASS (70121-1388-1)
70121-1389-7 70121-1389 HUMAN PRESCRIPTION DRUG Dexmedetomidine Hydrochloride Dexmedetomidine Hydrochloride INJECTION, SOLUTION INTRAVENOUS 20200520 N/A ANDA ANDA207551 Amneal Pharmaceuticals LLC DEXMEDETOMIDINE HYDROCHLORIDE 4 ug/mL 10 BOTTLE, GLASS in 1 CARTON (70121-1389-7) / 100 mL in 1 BOTTLE, GLASS (70121-1389-1)
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